"Monsanto should not have to vouchsafe the safety of biotech food," said Phil Angell, Monsanto's director of corporate communications. "Our interest is in selling as much of it as possible. Assuring its safety is the FDA's job." - New York Times, October 25, 1998

"What the FDA is doing and what the public thinks it's doing are as different as night and day." - Dr. Herbert Ley, Former FDA Commissioner

"The FDA serves as the pharmaceutical industry's watchdog, which can be called upon to attack and destroy a potential competitor under the guise of protecting the public." - Dr. James P. Carter

"Cynical & Dishonest Science" in GM Maize Trials

The maize trials in the UK's farm scale evaluations (FSEs) have come under fire for being "misleading", "worthless" and "a complete waste of time". Robert Vint and Lim Li Ching investigate.

sources for this article are posted on ISIS Members' website. Details here.

The FSEs compared the impact of managing GM herbicide-tolerant crops on farmland biodiversity, with that of their conventional counterparts. Three spring-sown crops were examined - beet, oilseed rape and maize. For beet and oilseed rape, clear negative impacts on farmland biodiversity were found (see "GM crops harm wildlife", www.i-sis.org.uk). GM herbicide-tolerant maize, however, was said to have positive effects, a claim widely highlighted in the media.

But the maize trials have been called into question.

Analysis of the methodology reveals systemic bias - underestimating the environmental impact of the GM crops whilst overestimating the likely environmental impact of future non-GM cultivation. The failure to measure the yield of the GM crop makes it impossible to confirm that the cultivation method was viable. In addition, published yield figures for the GM crop are derived from cultivation using a different herbicide, adding to the deception.

Environmental damage of GM crop underestimated

The GM maize used in the FSEs is Chardon LL (Liberty Link) developed by Aventis (now Bayer CropScience), and engineered to be tolerant to its Liberty herbicide (glufosinate ammonium). The GM maize herbicide management regime in the FSEs thus used Liberty, a herbicide less powerful than that used in the non-GM halves of the fields (see later).

However, research and farmers' experience have shown that the GM maize cannot be grown viably unless Liberty is mixed with other more aggressive herbicides. A Texas Agricultural Extension Service report, Weed Control in Liberty Link Corn 1996 to 1999 by Brent Bean and Matt Rowland, concludes that a single Liberty application should not be relied upon for season-long weed control and that control was greatly improved with the addition of atrazine. Similarly, a 1998 paper by Berzsenyi et al. concluded that in Hungary, "the results of field experiments showed that a weed management strategy with glufosinate must include multiple applications, residual herbicides or mechanical control".

Of US farmers growing Liberty Link GM maize, 75%-90% now need to use Liberty ATZ (a more powerful and environmentally harmful tank mix of Liberty and atrazine) rather than plain Liberty to obtain adequate weed control and maintain yields. Aventis/Bayer has marketed Liberty ATZ in the US for use on Liberty Link maize at least since 12 March 2001, as indicated on their product data sheet.

According to Pesticide Action Network UK, maize farmers in the UK have been using increasing amounts of atrazine in recent years. It seems highly likely that if UK farmers grow GM maize, they would want the same mixed formulations as US farmers - if not mixed with atrazine then with other powerful herbicides.

Furthermore, the spread of glufosinate-resistant weeds is a potential problem likely to make the use of Liberty ATZ almost essential in areas where GM maize has been grown for several years. US researchers have documented the emergence since 1996 of heritable glufosinate-resistance in ryegrass, goosegrass, horsetail and waterhemp in areas of high glufosinate (Liberty) use. In the absence of any UK research on Liberty-resistance in weeds, this must be assumed to be a likely problem to emerge in the UK.

If Liberty ATZ or any other Liberty-based herbicide mix was ever licensed for use in the UK, it would have a much more dramatic effect on biodiversity than the FSEs suggest.

The decision to use Liberty alone on the FSEs' GM maize, rather than Liberty ATZ or a mixture of Liberty and another herbicide, ensures that there will be more weeds and wildlife in the GM fields than would be likely under commercial cultivation and makes it unlikely that a commercially viable yield could be obtained. It also means that the GM maize plots were subjected to a herbicide management regime that is likely to quickly become obsolete.

This flaw was highlighted as early as 25 June 2002 in a BBC Newsnight programme 'Weeds fight back', and subsequently in The Times and Farmers Guardian, but no action seems to have been taken by the Scientific Steering Committee (SSC) overseeing the FSEs to correct this or even to discuss the matter. Furthermore, Aventis/Bayer must have known that Liberty on its own was ineffective, as it was already recommending in other countries that its Liberty ATZ be used in conjunction with its GM maize.

Subsequently, Brian Johnson, biotechnology adviser to the Government's advisory body English Nature, commented, "If I were being cynical I would say that Aventis told the government that only GA [glufosinate ammonium] would be used on these crops in the hope that more weeds would survive in the LL [Liberty Link] crops in the FSEs. If so, and I have no idea that this is right, then they could argue that the GM crops were better for the environment! They might then gain marketing consent for LL crops, only for the company then to change the pesticide recommendations to ATZ-type tank mixes."

Environmental damage of non-GM crop overestimated

The non-GM control crops in the FSEs were cultivated commercially by the farmers for sale or for feeding to their own dairy cows. In the overwhelming majority of cases, atrazine - a particularly toxic and persistent herbicide - was used on the conventional maize plots.

However, atrazine is now to be banned by the EU, a decision expected for several years because of its environmental impact. It was already banned in Austria, Denmark, Finland, Germany, Italy, the Netherlands and Sweden. This destroys the validity of the maize trials, as they no longer reflect the real conditions under which non-GM crops will be grown. Atrazine's replacement is likely to be less harmful to the environment.

The use of atrazine on the non-GM crop thereby misleadingly gives the impression that the GM crop is relatively benevolent.Michael Meacher, who as Environment Minister commissioned the trials, said "The ban on atrazine means that the trials are no longer valid because they no longer make a true comparison between the herbicides that would be used on GM and conventional maize... I do not see how the Government can now responsibly license GM crops."

Yield of GM crop not measured and may not be commercially viable

The suitability or otherwise of the herbicide regime used on the GM crop cannot be assessed because the crop yield was not measured. The FSEs were supposedly designed to mimic expected future UK commercial farming practice with GM crops, but FARM, the Independent Farmers' Union, argues that because no attention was paid to yield the maize trials cannot be shown to reflect normal commercial practice. Furthermore, there is no way of knowing whether commercial farmers would have been satisfied with this level of weed control or with the starch or dry matter yield of the resultant crop.

The measurement of biodiversity, which the FSEs studied, is a complex and time-consuming task. But the measurement of yield - which could be as simple and quick as weighing the crop or the cobs - was not even attempted in these £5.5 million trials. The farmers hosting the trials were merely asked to 'estimate' the success of the crop without providing any evidence!

Independent observers of the FSEs have reported low yields and fields full of weeds in the GM maize plots, raising suspicion that the GM crops were managed to limit adverse effects on wildlife, and not to maximise commercial yields. The results are thus irrelevant to farmers, who would not accept such yield penalties. The absence of yield measurements further increases suspicion that a deliberate attempt was made to conceal the commercial unviability of the herbicide regime selected.

Reported yield figures for GM crop based on different herbicide regime

The principal measurements of yield and dry matter reported for Chardon LL are derived from the National Seed List trials, which, in common with non-GM varieties, were grown using atrazine. However, as Chardon LL was engineered for use with Liberty, these figures are irrelevant and almost certainly misleadingly high. Most of the GM maize trials were treated with only one spray of Liberty at rates averaging just 3.5 litres of glufosinate per hectare (FSE report, p. 1815), allowing weeds to flourish, whereas a maximum total dose of 8 litres of glufosinate per hectare was permitted in the efficacy trials to efficiently kill weeds (PSD Notice 1123).

No green light for GM maize

John Sherrell, FARM founding member and South West dairy farmer, said: "These trials are completely useless for working farmers. Not only have they been invalidated by the use of the now banned herbicide atrazine, but they also provide no evidence of how these crops would perform under practical commercial conditions. It is amazing how the Government are trying to force farmers to grow these crops without providing the information farmers need."

GM Free Cymru has accused the SSC, which oversaw the FSEs, the Department for Environment, Food and Rural Affairs (DEFRA), and its scientific advisor, the Advisory Committee on Releases to the Environment (ACRE), of scientific fraud in the GM maize trials. In their view, the SSC should have recommended the cancellation of the maize trials as soon as it discovered that they were not replicating commercial management regimes.

Needless to say, the maize trials did not assess other important questions such as the threat posed to organic and other non-GM maize crops via pollen contamination, or the rate of emergence of Liberty-resistant weeds.

These flaws, in combination, render the FSEs of GM maize misleading and worthless. Ian Panton of GM Free Cymru said, "It would be an act of gross irresponsibility and negligence should the Government seek to authorise the commercialisation of GM maize on the basis of this cynical and dishonest science."

This article can be found on the I-SIS website at http://www.i-sis.org.uk/

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ISIS Press Release 12/03/04

Bogus Comparison in GM Maize Trial

The research paper claiming that GM maize is better for the environment than non-GM even if atrazine is not used is highly misleading. Prof. Peter Saunders and Dr. Mae-Wan Ho report

Caught between fierce opposition from the public and heavy pressure from the biotech industry, the UK government agreed in 2000 to fund the 'Farm Scale Evaluations' (FSEs) at a cost of £3 million to the taxpayer. Three genetically modified herbicide tolerant (GMHT) crops - maize, oilseed rape and sugar beet - would be grown side by side with conventionally managed counterparts, so they could be compared.

The FSEs were severely criticised for being rigged in favour of the industry right from the start. First of all, organically managed crops were not included in the evaluations, nor were the crops grown under other low-input, integrated management regimes.

The FSEs were not intended to address safety issues, as these were assumed to have been satisfactorily resolved. There would be no evaluations on the risks of gene-flow, nor threats to a whole range of wildlife, livestock or human beings, nor effects on the soil ecosystem. There would be no data collected on yields or other important agronomic indicators.

The FSEs would estimate the effects on biodiversity using only a few indicator species of weeds and insects; and if these proved to be the same, or "substantially equivalent", then the GM crops would be given the go-ahead.

It is rather like giving a MOT certificate to a car just by checking that the tyres are OK.

But to everyone's surprise, when the results were published, it turned out that GM oilseed rape and sugar beet had a more deleterious effect on biodiversity than conventionally managed crops. GM maize, however, appeared to do better than the conventional maize crop. The Government therefore announced that it would permit GM maize to be grown commercially but not the other two.

This was a very convenient result. It allowed the Government to portray itself as being very cautious and responsive to scientific evidence and, at the same time, let the GM lobby go ahead with commercial growing of GM crops. What is at stake is the principle that GM crops can be grown commercially in the UK, and it matters little whether it is maize, oilseed rape or sugar beet. Once one GM variety has been agreed, then more will follow, if for no other reason than that pollen from GM variety will pollute the non-GM varieties, as is already happening in North America and elsewhere.

Unfortunately, there was a snag. Almost all the conventional GM maize had been treated with atrazine or other triazine herbicides, and just as the results were announced, the EU banned these herbicides on environmental grounds. This meant that the maize trial results were no longer valid.

Then, just before the environment secretary Margaret Beckett was due to give the official go- ahead for the GM maize, a paper that claimed to rescue the Government's case was rushed online in the high prestige journal Nature. It bore the confident title: "Ban on triazine herbicides likely to reduce but not negate relative benefits of GMHT maize cropping." The eleven authors of this paper come from a whole collection of Government-funded Institutes: Rothamsted Research in Harpenden, Hertfordshire, NERC Centre for Ecology and Hydrology, Lancaster, Cumbria, Broom's Barn Research Station in Bury St. Edmunds, Suffolk, NERC Centre for Ecology and Hydrology in Huntingdon, Cambridgeshire and Scottish Crop Research Institute in Dundee, Scotland.

The claim is that, according to further statistical analysis, the ban on triazine herbicides, although it might reduce the benefits of GM maize, is unlikely to cancel them out altogether. This would be a very significant result, if only it were true.

From the data presented in the paper, there were indeed a few fields - four of them to be exact - where non-triazine herbicides were used. Did the researchers compare those to the GM maize fields in order to arrive at their conclusion? No. Possibly because there was no significant difference between the two groups, and in any case, the number of plots was too few to support the claim that the GM maize would be better from the standpoint of biodiversity.

So what did they do instead? The authors noted that on 16 occasions, triazine herbicides had been applied before the maize emerged. On 24 occasions, it had been applied post-emergence only, as had the non-triazine herbicides. They decided to leave out the data from the plots on which triazine was applied pre-emergence, which clearly showed a greater deleterious effect on biodiversity than any other treatment.

The GM maize was thus compared with data from the 24 plots on which the now banned triazine herbicides had been used post-emergence plus the 4 on which non-triazine herbicides were used. There was now a significant difference, which allowed the lead researcher, Perry, to say on the BBC Radio 4 Today Programme that about one-third of the benefits of GM maize would remain after triazines are no longer used.

But this is a highly misleading claim, because 24 out of the 28 plots compared with the GM maize had in fact been sprayed with the banned triazines.

They write in the paper, "If this pooled category of herbicide regimes is indeed representative of weed control in post-triazine conventional crops, and if the weed management in GMHT maize remains the same as observed with the FSE, then final weed numbers would still be larger in GMHT than in conventional maize." There is nothing that would justify the first half of this statement (in fact the authors themselves point out that the non-triazine herbicides had a consistently smaller effect on biodiversity than triazines) and so the claim in the title of the paper is simply bogus.

In reply to criticisms from the House of Commons Environment Audit Committee reported in the Times newspaper, Les Firbank, one of the authors of the Nature paper and also the coordinator of the FSEs, wrote,

"I find it astonishing that the chairman of the committee should announce that the work is "neither robust nor particularly credible science" within a few hours of its publication in Nature, the most highly acclaimed scientific journal in the world."

We find it astonishing that the paper got past the referees of any respectable journal, let alone "Nature, the most highly acclaimed scientific journal in the world".

But that's not the whole the story. The reason yield is not measured is because, if it were, it would very likely reveal a highly significant difference between the GM maize and non-GM maize fields.

Jean Saunders, a citizen opposing the planting of GM crops, has taken the trouble of photographing her local GM maize trial (see the powerpoint presentation here), documenting the severe stunting of the GM maize crop, delayed flowering, and much smaller and fewer cobs compared with the conventional non-GM maize. This finding is surely a lot more relevant to the farmer than data that the scientists have collected and the spin that they have put on the data to allow commercial approval to go ahead.

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ISIS Press Release 13/03/04

Exposed: More Shoddy Science in GM Maize Approval

Dr. Mae-Wan Ho The Food Standards Agency appears to be selectively promoting and suppressing research results in projects it funds

Scientists should be afraid, very afraid of the extent to which the academic-industrial-military complex is bending science to suit its purpose. No, I am not only speaking about the United States, but the United Kingdom here.

Horizontal gene transfer - a major uncertainty in GM safety

In the current issue of Science in Parliament [1], I found no less than three mentions of horizontal gene transfer as a major uncertainty in the safety of GM crops: in an article by Michael Meacher MP, "GM: the politics of uncertainty", in a Parliamentary debate on biotechnology by Joan Ruddock, and in the article " Nanotechnology: friend or foe?" by Prof. George Smith of Oxford University.

Horizontal gene transfer is the process whereby genetic material jumps into foreign genomes, or put the other way round, whereby foreign genetic material jumps into genomes. That is exactly what genetic modification involves: artificially constructed DNA (called GM DNA or transgenic DNA) cobbled together from a wide variety of sources or simply made in the laboratory, is inserted into the genomes plants, animals and livestock.

But horizontal gene transfer can also happen unintentionally and without our knowledge. It is the main process creating new viruses and bacteria that cause disease epidemics and spreads antibiotic and drug resistance besides, making the diseases more difficult to treat. Foreign genes jumping into genomes, as many investigations on the genetic modification process itself reveal, causes extensive genetic damage, scrambling and rearranging genomes, resulting in inappropriate gene expression that can trigger cancer.

There's lots of evidence that transgenic DNA may be more unstable and more mobile than natural DNA [2], and molecular analyses of commercially approved GM crops, carried out belatedly last year, found that practically all the inserts have rearranged since characterised by the company [3,4].

One big question is: what happens to the transgenic DNA that's in GM food and feed? I have raised this question on numerous occasions with our government over the past ten years, one of the more recent occasions during the public hearing on Chardon LL T25 transgenic maize organised by the Advisory Committee on Releases to the Environment (ACRE) in 2002 [5].

At the same hearing, it was revealed that twice as many broiler chickens died eating GM maize as non-GM maize. But because the experimental design was so flawed, statistical analysis failed to detect a significant difference between the two groups. Prof. Orskov of the Macaulay Institute raised the issue of whether milk from dairy cows was safe to drink, and spokespersons from Friends of the Earth also pressed for feeding tests in the appropriate species - cattle - instead of rats and broiler chickens.

ACRE's written response to the Chardon LL Hearing (December 2002) stated [6]: "The Company - Bayer - has commissioned a dairy cattle feeding study with T25 maize and will present the data to the French competent authorities when completed. As is the standard practice, ACRE will review new information generated in this trial and update the risk assessment accordingly."

Mystery of the missing study

But the result of this study has yet to see the light even though the GM maize has now been approved for commercial growing as cattle feed.

Dr. Brian John of GM-Free Cymru wrote to ACRE 24 February expressing his concern that there are no published or peer-reviewed ruminant feeding studies on the effects of T25 maize [7] and asked to see the study mentioned by ACRE, especially in view of the recent report that twelve dairy cows in Hesse Germany died after eating Syngenta's GM maize 176 [8]. ACRE has not replied, despite a reminder sent 5 March.

The study was supposed to have been done by Professor Richard Phipps in the Centre for Dairy Research (CEDAR) at Reading University.

"There is no mention of the study on the CEDAR website." Brian John said, "If the Chardon LL used in the study came from the FSE trial sites, that would have contravened the FSE rules, and a separate consent must have been signed by somebody."

Bayer was reportedly given a report of the study late in 2002, and one of the researchers involved, David Beever, claimed the report had gone to ACRE.

On 9 March, Brian John finally received, via the Welsh Assembly, a "Background Information" paper from Richard Phipps, stating that the study was conducted at the University of Reading for Bayer Crop Science. The objective of the study was to determine the effect of silage derived from T25 maize on feed intake and milk production in lactating dairy cows compared with a near isogenic counterpart and silage of two further commercial maize hybrids.

Furthermore, it stated that the study has been completed and presented to the company, and they are in the process of preparing their data for publication in an international scientific journal once the peer review process has been completed, the same process followed in the study they conducted for the UK Food Standards Agency, published in the Journal of Dairy Science [9], a copy of which was enclosed.

They then went on to state,

"While it is not our policy to release details of studies prior to peer review we feel able to say that the compositional, fermentation characteristics and nutritional values of all four silages were comparable and that there were no significant differences in milk yield, milk composition and yield of milk constituents, when comparing the four rations. In addition GM DNA was not detected in any of the milk samples analysed by Polymerase Chain Reaction methodology. Cows remained in good health throughout the study period."

Notice that the study focussed on silage, not on maize grain, which is also widely fed to cattle. It concentrated on detecting GM DNA in milk, but not the mouth, rumen or intestinal contents, blood, meat or other animal tissues, where positive results have already been reported (see below).

The FSA-sponsored study is presumably the reason our government has given the go-ahead for approving Chardon LL T25 maize to be grown for cattle feed, as the T25 study has yet to be published and there is a dearth of published studies on feeding ruminants with GM feed. So, how does that study stand up to scrutiny?

Study that found no results worth reporting is worthless

The study failed to find significant survival of GM DNA, or indeed any single copy DNA in most of the tissue and tissue contents examined; but it is deeply flawed.

First of all, the FSA-sponsored study has nothing to do with Chardon LL maize. It was work carried out with a mixture of both Monsanto's Roundup Ready soya GTS 40-3-2 (as soya meal) and Mon 810 maize (as maize grain) at the same time, comprising only 13% and 18.5% respectively of the total diet. This inevitably decreases the chance of detecting the GM DNA belonging to the varieties.

Second, only six cows were used, three fed the GM diet and the other non-GM. But a peculiar "single reversal design with three 4-wk periods" was used, which I believe, meant that the groups of three cows alternated between GM and non- GM diets. Thus one group would spend the first four weeks on GM, the next four weeks on non-GM and then four weeks back on GM; while the feeding regime for the other group would be non-GM, GM, and non-GM. This design generates in effect 9 data points each for the GM diet and non-GM diet. But, it also guarantees to balance out the effects of GM versus non- GM diet and hence is utterly worthless as far as detecting difference in weight gain or any other developmental or physiological indicators between the diets.

Third, the researchers made a big blunder. Two of the cows in the non-GM group were inadvertently fed on the GM-diet, so they ended up with 13 data points in the GM diet group and only 5 data points in the control non-GM diet group.

Fourth, even though they had taken apparently carefully timed samples from individual animals in each four week period, they pooled all the samples from the same animal together, thus losing potentially valuable information regarding the time course of the clearing of GM DNA from the gut to the tissues and out of the body.

Fifth, and most serious of all, their PCR method for detecting GM DNA is neither validated nor standardized. Its sensitivity varied over 1000 fold between different tissues and tissue- contents. The limits of detection is such that in some samples, I calculate that more than 4 000 copies of the soya genome or 900 copies of the maize genome must be present in the sample before a positive result is obtained. The usual detection limit of PCR is 10 copies or less. Thus, given the minute amounts of tissues and tissue contents used in a PCR test, as for example, 0.3 millilitres of milk, it is no wonder that the only DNA that can be detected at all reliably is the chloroplast gene, which exists in 10 000 copies per plant cell. And no wonder there is a rather large number of neither positives nor negatives, but "inconclusives" in the data.

Poor PCR amplification is one of the most common causes of failing to detect GM DNA

The "Background Information" on the study on Chardon LL claims that their as yet unpublished results "support the 30 other peer-reviewed papers in international scientific journals, which have failed to detect GM DNA in milk, meat and eggs derived from animals fed diets containing GM feeds."

In fact, poor PCR amplification is probably one of the most common causes of having "failed to detect GM DNA". A Japanese research team, which has documented the survival of both GM DNA and Bt toxin protein in the digestive tract of mice, pigs and cattle [10], nevertheless reported a failure to detect GM DNA in blood because as they stated, the PCR did not work in blood. There are many unknown PCR inhibitors in different tissues that can give false negatives. Phipps and coworkers also failed to detect single-copy DNA in blood, GM or otherwise, they failed to detect even the abundant chloroplast gene in the vast majority of samples.

GM DNA found to survive when PCR is adequate

One recent study documenting the survival of GM DNA in the mouth and rumen of sheep was also funded by the Food Standards Agency [11]. This research group from Leeds University found that DNA fragments containing the entire coding region of the synthetic cry1Ab gene was still amplifiable from rumen fluid 5 hours after feeding maize grains, though not from rumen fluid sampled from sheep fed silage prepared from the genetically modified maize line. But PCR amplification of a shorter (211-bp) sequence was possible with rumen fluid sampled up to 3 and 24 h after feeding silage and maize grains, respectively.

It is clear that GM DNA in maize grains persists, and "may, therefore, provide a source of transforming DNA in the rumen".

But the authors are wrong to claim that the 211-bp sequence is "very unlikely to transmit genetic information". For such sequences could be promoters or enhancers containing hundreds of binding motifs for transcription factors, and capable of boosting the expression of genes inappropriately.

The researchers also found that plasmid DNA introduced into the mouth of sheep and extracted from saliva sampled after 8min was still capable of transforming Escherichia coli bacteria to kanamycin resistance, "implying that DNA released from the diet within the mouth may retain sufficient biological activity for the transformation of competent oral bacteria".

They conclude: "The use of GM crops harbouring antibiotic resistance genes, in particular the use of unprocessed grains in animal feed, possibly deserves further evaluation."

A great deal of uncertainty remains over the fate of GM DNA. Further research must be carried out with properly validated quantitative PCR methods.

ISIS has discovered that information on this research is not easily found on the FSA website, although the FSA has clearly funded the research (the research grant is G01010). The FSA website does have information on the research they fund (there is a Research Project List for its Safety of Novel Foods Research Programme), some with the papers themselves, others with just short information on the projects; this is available for G01007-G01021, with the exception of G01010 and G01014. A search of the FSA website with the term 'G01010' eventually turned up some information on the project, although not the papers arising from the research.

References

Science in Parliament 2004, Spring, The Parliamentary and Scientific Committee.

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No credible evidence that NK603xMon810 is safe for animal and human health The Assessment Report C/GB/02/M3/03 contains no credible evidence that NK603xMon810 is safe for animal and human health.

No independent molecular data were provided to ascertain that the transgene inserts are stable as claimed by the company

No independent molecular data were provided to ascertain that the transgene inserts remained stable in the seeds set that will be used for animal feed and human food

No toxicological studies were carried out

No tests for allergenicity were conducted

No feeding trials were done on cows or pigs

No data accompanied Monsanto's own feeding trial on chickens

Not a single reference was made to peer- reviewed scientific literature

Thus, there is no justification for the advice from ACRE (Advisory Committee for Releases to the Environment) that this hybrid GM maize "does not pose a risk to human health or the environment".

ACRE has ignored all evidence to the contraryOn the contrary, ACRE has totally ignored existing evidence suggesting that NK603xMon810 may not be safe. We consider first the parental lines, Mon810 and NK603.

1. Parental lines proven unstable and hence illegal under European legislationThe transgene insert in the parental line Mon810 has proven to be unstable, i.e., it has rearranged since characterized by the company [1-5]. Likewise, the transgene insert in the NK603 line was also found to have rearranged [6], which may be part of the reason why its application for import into Europe for food and processing has failed to gain the required majority vote in the Regulatory Committee on the release of GMOs into the environment on 18 February 2004.

According to the new European Directive for deliberate release 2001/18/EC, event specific characterization of the transgenic insert as proof of transgenic stability is required for approval. Such even- specific characterization is also necessary to satisfy EC Novel Foods Regulation 258/97 and regulations 1139/98/EG and 49/2000 for traceability and labeling. Thus, both parental lines should be considered illegal within current European legislation. This applies all the more so to the hybrid NK603xMon810 derived from the two parental lines.

2. NK603xMon810 needs to be characterized for stabilityIndependent re-characterization of the transgenic inserts in NK603xMon810 is required because of the strong possibility of non-homologous recombinations (genome scrambling) between the two non- allelic inserts in the parental lines which nevertheless possess sequence homologies, specifically, in the cauliflower mosaic virus (CaMV) 35S promoter with enhancer (e35S) and the hsp70 intron used to drive transgene expression in both events NK603 and Mon810.

3. Transgene instability is above all a safety issueThe stability of the transgene insert in a GMO is above all a safety issue. The fact that the transgenic lines have undergone genetic rearrangement since the company carried out safety tests automatically invalidates all those tests. As everyone knows, the characteristics of a transgenic line depend entirely on where in the genome and in what form the inserts have integrated; if an insert has rearranged or moved elsewhere, then the transgenic line, by definition, has lost its original identity and become a different line.

4. Mon810 insert associated with a mobile genetic elementThe insert for Mon810 has been extensively characterized in the published literature. The host genome flanking the 5' (head) end of the insert shows homology to the long terminal repeats (LTR) of the maize alpha Zein gene cluster; but no homology to the maize genome was detected at the 3' site, indicating that there had been scrambling of the maize genome at the insertion site [1-3]. Long terminal repeats are found in mobile genetic elements and often contain strong promoters that respond to environmental signals. That not only makes secondary mobility of the insert (horizontal gene transfer) much more likely, but also lead to major disturbances in host gene expression.

Transgene inserts in general show a strong preference for mobile genetic elements. One study [1] found that the insert in Chardon LL T25, recently approved by the UK government for commercial growing, is located in a retrotransposon.

5. The CaMV 35S promoter remains a major safety concernWe have raised serious safety concerns over the CaMV 35S promoter, which is known to have a recombination hotspot and to be active in species across the living world, including human cells [7- 9]. We note that both events NK603 and Mon810 have transgenes driven by this promoter, as have other GM maize lines that the UK government has recently approved: Bayer's Chardon LL T25, and Syngenta's Bt 176. The safety of this promoter has been set as one of a list of "self tasking activities" recorded in the minutes of the European Food Safety Authority 5th Plenary Meeting of the Scientific Panel on Genetically Modified Organisms held on 11 December 2003 [10]. The relevant paragraph is reproduced below:

"10. TERMS OF REFERENCE FOR SELF TASKING ACTIVITIESThe members of the GMO Panel are invited to provide written comments by the next plenary meeting on the following proposals for self tasking activities:- Impact of GMOs on microbial biodiversity and function in the soil environment- Post market monitoring of crops- Assessment of allergenicity of genetically modified (GM) foods- Post market surveillance of genetically modified (GM) foods- Safety of use of viral promoters and specifically of the cauliflower mosaic virus (CaMV) promoter. "The minutes of the subsequent meeting held in January 2004, recorded that this issue remains unresolved, and is "deferred to a later stage" [11].

Syngenta's Bt176Between 2001 and 2002, 12 dairy cows died on a farm in Woelfersheim in the state of Hesse in Germany after being fed Syngenta's Bt 176 maize; and other animals in the same herd had to be slaughtered on account of mysterious illnesses [12]. The Robert Koch Institute made little attempt to investigate the deaths and illnesses and the local district council in Giessen issued a statement in August 2003 stating that "the cause of incidents referred to could not be determined."

We pointed out [13] that Bt 176 suffers from the worst transgenic instability of all the transgenic lines examined recently by French and Belgian government scientists, who found that the company may also have misidentified or misreported the particular Cry1A protein present. Syngenta claims that the transgene in Bt176 is crylAb, but on analysis, the sequence of the transgene was 94% similar to a synthetic crylAc gene, and has only 65% homology with the native cry1Ab gene of Bacillus thuringiensis subsp kurstaki, from which it was supposed to have been derived.

This incident highlights the regulatory sham surrounding Bt crops [14, 15]. Bt toxins encompass a large superfamily of Cry proteins made by different strains of B. thuringiensis. The Bt transgenes incorporated into GM crops, however, are often synthesized in the laboratory, containing truncated (pre- activated) versions of the natural toxins (as in the case of Mon810) which means that they can harm non-target insects and other animals, or changes in amino acid sequences, or hybrid sequences of two or more Cry toxins, such that the toxicities to insect pests and other animals are totally unknown and untested. Yet, regulators have routinely accepted toxicity and allergenicity tests based on the natural toxins isolated from B. thuringiensis.

Mon810Last year, scores of villagers in the south of the Philippines living near fields planted with Dekalb 818 YG - which turns out to be a hybrid between Mon810 and a locally adapted variety (Dekalb 818) - became ill when the maize started to flower. Dr. Terje Traavik, director of the Norwegian Institute of Gene Ecology, found antibodies reacting against the Bt toxin Cry1Ab, which is produced by Mon810, in the sera of 39 farmers who were affected. He reported this finding, along with other results of research in progress during a workshop preceding the Meeting of the Parties of the Cartagena Biosafety Protocol in Kuala Lumpur, Malaysia on 22 February 2004. He considered those results too important for public health to wait until the scientific reports appear in print after a lengthy "peer-review" process, and wanted to issue a timely warning to the delegates attending the official biosafety meeting

This provoked an immediate reaction from the pro-GM lobby, which has been running a campaign to discredit Traavik ever since. Traavik has reaffirmed his findings in answer to his critics [16]:

"We have used direct and inhibitory ELISAs (enzyme-linked immuno-sorbent assays) to demonstrate IgA, IgG and IgM antibodies specifically binding to Bt-toxin Cry1Ab in sera from Philippine farmers. A general interpretation would be that the farmers had been exposed, in an immunologically meaningful way, to Cry1Ab, or an antigen sharing epitopes with Cry1Ab, during the last 6-9 months before blood samples were taken. This might indicate coincidence in time between three observed events: the very first pollination season for Bt-transgenic maize, an outbreak of respiratory/intestinal disease among individuals living close to the Bt-maize field, and the production of serum antibodies. I strongly emphasized that the tests could not establish any cause-effect relationships between the 3 events, neither could the results preclude such relationships, and hence they might represent an early warning. As I said at the time, even if I had been able to present the detection of specific anti-Cry1Ab IgE antibodies, my conclusions would have been the same."

The companies have repeatedly denied that Bt toxins are allergenic, but there are reports in scientific literature that Cry1Ac is a strong immunogen [17- 19], and hence a potential allergen. Cry1Ac shares many Cry1A epitopes with CrylAb. Furthermore, as Travvik points out, "Bacillus thuringiensis spraying has elicited specific Cry1A antibodies in farm workers, within the same classes we detected, as well as allergy-related IgE antibodies. These findings were published already in 1999.." [20].

Recently, researchers in Japan's National Institutes of Animal Health, Food Research, and Livestock and Grassland Science found that Cry1Ab protein in GM maize Bt11 survives digestion in the gut of pigs [21, 22]. Its digestibility was estimated to be 92% by comparison with indigestible chromic oxide. Researchers from the Center for Genetic Engineering and Biotechnology in Havana Cuba had earlier identified 6 proteins in the brush border that bind specifically to Cry1Ac [23, 24], a toxin in the same family as Cry1Ab.

ConclusionIn conclusion, we consider the approval of NK603xMon810 and other GM maize mentioned, T25 and Bt176, to be a serious abuse of science in face of scientific and other evidence indicating that these GM crops pose serious health risks.

"Opinion of the Scientific Panel on Genetically Modified Organisms on a request from the Commission related to the safety of food and food ingredients derived from herbicide-tolerant genetically modified maize NK603, for which a request for placing on the market was submitted under Article 4 of the Novel Food Regulation (EC) No 258/97 by Monsanto (Question No EFSA-Q- 2003-002) The EFSA Journal 2003, 9, 1-14.European Food Safety Authority www.efsa.eu.int/science/gmo/gmo_opinions/177_en.html

Minutes of the European Food Safety Authority 5th Plenary Meeting of the Scientific Panel on Genetically Modified Organisms held on 11 December 2003 http://www.efsa.eu.int/science/sci_commitee/ sci_meetings/238_en.html

Minutes of the European Food Safety Authority 6th Plenary Meeting of the Scientific Panel on Genetically Modified Organisms held 20 and 21 January 2004 (adopted 10 February 2004) http://www.efsa.eu.int/science/sci_commitee/ sci_meetings/244_en.html

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